Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide content of labeling in Structured Product Labeling format. Please provide carton and container labeling in Structured Product Labeling format, as well as three original paper copies.

We will include the information contained in the above referenced supplement in your Biologics License Application file.

Sincerely yours,

Wellington Sun, M.D.DirectorDivision of Vaccines andRelated Products ApplicationsOffice of VaccinesResearch and ReviewCenter for BiologicsEvaluation and Research